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Completed

NCT Number: NCT01540812

Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

Trial protocol intended the optimization of induction treatment with:

1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation. 2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration 3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making.

For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy.

Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second.

Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ALL de novo high-risk criteria
  • Age 15-55 years (55-60 years patients will be included at the discretion of the medical team that will attend)
  • No prior treatment, except Emergency leukapheresis Emergency treatment of hyperleukocytosis with hydroxyurea Urgent cranial irradiation (one dose) for CNS leukostasis Mediastinal irradiation for urgent superior vena cava syndrome
  • General condition suitable scale (ECOG 0-2), or> 2 if due to ALL
  • Negative pregnancy test for women of childbearing age
  • Written informed consent because, although the protocol does not include the use of investigational drugs, biological samples sent there for them

Exclusion criteria

  • L3 type ALL or mature phenotype B (sIg +) or cytogenetic abnormalities characteristic of mature B-ALL (t (8; 14), t (2, 8), t (8; 22)). For these patients is available BURKIMAB protocol.
  • LAL Ph (BCR-ABL) positive. For these patients have the protocol ALL-Ph-08 (if under 55) or LALOPh (if over 55).
  • Lymphoid blast crisis of chronic myeloid leukemia
  • Biphenotypic acute leukemia or bilinear according to the criteria of EGIL group
  • Undifferentiated acute leukemias
  • Patients with a history of coronary artery disease, valvular or hypertensive heart disease, contraindicating the use of anthracyclines
  • Patients with chronic phase of activity
  • Patients with severe chronic respiratory failure
  • Kidney failure due to ALL
  • Serious neurological disorder not due to the LAL
  • History of pancreatitis
  • Pregnancy or breastfeeding
  • Mental or psychiatric illness preventing informed consent is given for sending samples or properly follow the study
  • General condition affected, not attributable to the ALL

Treatment and study plan

Vincristine in induction

Drug

Daunorubicin in induction

Drug

Prednisone in induction

Drug

Metotrexato in induction

Drug

Cytarabine in induction

Drug

Hydrocortisone in induction

Drug

Idarubicin in induction-2

Drug

Fludarabine in induction-2

Drug

Ara-C in induction-2

Drug

G-CSF in induction-2

Drug

Dexamethasone in consolidation-1

Drug

Vincristrine in consolidation-1

Drug

Metotrexato in consolidation-1

Drug

PEG-ASP in consolidation-1

Drug

Dexamethasone in consolidation-2

Drug

ARA-C in consolidation-2

Drug

PEG-ASP in consolidation-2

Drug

Dexamethasone in consolidation-3

Drug

Vincristine in consolidation-3

Drug

Metotrexato in consolidation-3

Drug

PEG-ASP in consolidation-3

Drug

allogeneic HSCT

Procedure

Allo HSCT with reduced-intensity conditioning

Procedure

Primary outcomes

  1. Overall response rate

    Time frame: 2 years

    Improve the results of the protocol ALL-AR-03 with modifications in the study methodology of residual disease: centralized, Biomed protocols and the cut-off - <0.01% - internationally accepted and changes in the induction and consolidation treatment, without altering the overall design

Secondary outcomes

  1. Evaluate CR rate with addition of PEG-ASP in the induction phase

    Time frame: 2 years

  2. Standarization of minimal residual disease

    Time frame: 2 years

    Determination of minimal residual disease in a central laboratory trying to homogenice the results

  3. To assess the toxic mortality

    Time frame: 2 years

    To assess whether the reduction of daunorubicin in induction and changes in the consolidation drugs reduce toxic mortality in patients in complete remission

  4. Assess the proportion of non-responders or slow responders

    Time frame: 2 years

  5. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 29, 2012
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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